FibriCheck

Transmitters And Receivers, Electrocardiograph, Telephone

Qompium Nv

The following data is part of a premarket notification filed by Qompium Nv with the FDA for Fibricheck.

Pre-market Notification Details

• Device ID: K173872
• 510k Number: K173872
• Device Name: FibriCheck
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: Qompium Nv Kempische Steenweg 311/27 Hasselt, BE 3500
• Contact: Jo Van Der Auwera
• Correspondent: Patsy Trisler; Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, MD 20815
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-12-20
• Decision Date: 2018-09-28
• Summary: summary